Samples received: 4 open and used units and 1 unopened unit.Analysis and results: there are five previous complaints of the same code-batch, 4 of them regarding a similar issue but closed as not confirmed after analysis.We have received 1 unopened and 4 open and used samples.1) visual inspection of the returned staplers: closed sample: stapler 1: this stapler was not used.So, all staples were in the cartridge in line correctly.Open samples: stapler 2: 28 pieces of staples were left in the cartridge not uniform.Some dirt was observed.Stapler 3: 5 pieces of staples were left in the cartridge in line correctly.Stapler 4: 14 pieces of staples were left in the cartridge not uniform.The left side of release area of the cartridge was turned up.Stapler 5: 13 pieces of staples were left in the cartridge not uniform.The left side of release area of the cartridge was turned up.The latch of the cartridge was turned up.The latch of the cartridge was unhooked.2) reproducibility test before disassembling the returned staplers.Closed sample: stapler 1: no problem was observed.All staples were released properly and stapling function worked without any problems.Open samples: stapler 2: no problem was observed.The remaining staples were released without problems.Stapler 3: the remaining staples were released but there was with some snap sound.Stapler 4: the second staple of the remaining staples was released in a bad shape.Stapler 5: the remaining staples were release with a snap sound and in bad shape on a rubber.3) disassembled components check of the returned stapler 4 and 5: no problem was found with the measured values of each component of the returned stapler 4 and 5.Left side groove of the ram was deformed.Both corners of anvil were worn.4) reproducibility test after reassembling with new anvil, and reloaded 36 pieces of staples into the returned stapler 4 and 5.All the staples were released properly and stapling function worked without any problems.As the result of the investigation, no problem was found with the production record and measured values of each component of all the returned staplers.Unhooked latch and damaged components such as anvil and ram were observed with the returned stapler 4 and 5, and reproducibility was observed with these two staplers.However, when damaged components were replaced with hooked latch, stapling function worked properly.It is highly probable that an unexpected overload of pressure or usage was applied to the products during the application and some of the components were damaged causing the malfunction under an unexpected situation.Final conclusion: although reproducibility was observed on 2 of the open and used returned staplers, it has been observed that probably an unexpected overload of pressure or usage was applied to the products during application and some of the components were damaged causing the malfunctioning under an unexpected situation.The other samples received fulfill the product specifications.Nevertheless, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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